Enoxaparin Sodium Injection, USP NDC Change

Dear Healthcare Provider,

In our mission to solve healthcare challenges by building authentic relationships, providing innovative, value-based solutions, and keeping our promises, Meitheal Pharmaceuticals, Inc. encourages and values customer feedback. We are pleased to share some new changes to our Enoxaparin Sodium Injection, USP Pre-Filled Syringe line.

In 2023, we will start distributing the Enoxaparin Sodium Injection, USP Pre-Filled Syringes with the following changes:

• New safety device on the syringe and a larger plunger rod.
• New Instructions for Use leaflet (IFU) per each unit that can be provided to customers.
• New NDC numbers.

The changes to the safety device and larger plunger, are based on extensive customer feedback, and intended to provide a smoother, improved activation. Please note, the new safety device will function the same as the current version.

The change to NDC numbers was requested by the FDA to have clear, distinct NDC numbers at all levels of labeling for our Enoxaparin Sodium Injection, USP product family. The updated NDC numbers are an additional measure being taken to ensure no medication errors or safety concerns. Meitheal Pharmaceuticals, Inc. has updated our NDC numbers in accordance with the Agency’s request. The following assessment of our old NDC numbers was done to demonstrate that the current on market product poses little safety concerns:

• The NDC in its entirety (labeler code, product code, and package code) has distinct numbers.
• Enoxaparin Sodium Injection, USP uses color prudently to bring attention to the product name and strength to limit any confusion about the strength of the product.
• Each product code of Enoxaparin Sodium Injection, USP has a specific differentiating color assigned to each strength to ensure the end-user administers the proper drug product as laid out in Prescribing Information. For a specific product code, the labeling of the syringe, blister, and carton along with the plunger has the same color.
• Each Enoxaparin Sodium Injection, USP Meitheal product has a specific Global Trade Item Number (“GTIN”) with an associated unique barcode. When used in a clinical setting, these unique GTINs and barcodes are scanned to ensure the proper product is being prescribed. This unique coding limits any confusion in dispensing the appropriate Enoxaparin Sodium Injection, USP.
• A review of our safety database from the day of approval (November 29, 2019, to current) does not show any medication errors.

The timing of transitioning to the new product with new NDC numbers will vary depending on the strength of Enoxaparin. Meitheal Pharmaceuticals, Inc. will provide frequent updates on current inventory levels and transition timing to ensure there is no service disruption. Below please find a list of the current and new NDC numbers for your reference.